Record of Telephone Conversation, October 13, 2011 - MenHibrix

Submission Type: BLA    Submission ID: 125363/0    Office: OVRR
 

Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
 

Applicant:
GlaxoSmithKline Biologicals
 

Telecon Date/Time: 13-Oct-2011 03:30 PM        Initiated by FDA? Yes
 

Telephone Number: jody.a.gould@gsk.com
 

Communication Categorie(s):
1. Advice

Author: KIRK PRUTZMAN
 

Telecon Summary:
Item 2.b.i Clarification Response
 

FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, DAVID STATEN
 

Non-FDA Participants: JODY GOULD
 

Trans-BLA Group: No

Related STNs: None
 

Related PMCs: None
 

Telecon Body:

From: Prutzman, Kirk C
 

Sent: Thursday, October 13, 2011 3:25 PM
 

To: 'Jody Gould'
 

Cc: Temenak, Joseph; Staten, David
 

Subject: RE: BL/STN 125363 MenHibrix - Request for Clarification

Jody,

We have received a response from our review team regarding clarification of Item 2.b.i.  Briefly, the reviewer is concerned about the impact of the –b(4)---------- on the variance of the samples that would be dependent on the titer of the sample.  This is essentially your "second suggestion" in your email below.  Let me know if this needs further clarification.

Regarding your submission of Item 26.  Sean Byrd has received the manual visual inspection data and is currently reviewing it.  There are no comments at this time. 

We have also received your intent to file amendment. 

Regards,

Kirk

--------------------------------------------------------------------------------

From: Jody Gould [mailto:jody.a.gould@gsk.com]
 

Sent: Wednesday, September 28, 2011 11:43 AM
 

To: Prutzman, Kirk C
 

Subject: BL/STN 125363 MenHibrix - Request for Clarification
 

Importance: High

Dear Kirk,

I am writing to request clarification on one question in the September 21 CR letter.

Specifically, we would like clarification of the sentence in Item 2.b.i:  Please show that the –b(4)-------- algorithm is independent of sample titer, i.e., that the variance of the         --b(4)---------- ratio is constant relative to titer.

Could the reviewer please clarify if this refers to variation of the variance due to the titers of the controls, or to an impact of the ---b(4)------- factor on the variance of the samples that would be dependent on the samples’ titers.

Note that we may have additional items for clarification as we continue to review the letter and assess CBER’s requests in detail.

Also, in case you haven’t seen them yet:

-          Manual visual inspection information (response to request from S. Byrd) was submitted on September 23.

-          Intent to File Amendment was submitted on September 26.

Thank you!

Jody

Jody Ann Gould, PhD
Senior Director
US Regulatory Affairs
jody.a.gould@gsk.com
610-787-3765 (phone)
610-787-7063 (fax)

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